Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K980420 |
Device Name |
LIGHTSHEER |
Applicant |
PALOMAR MEDICAL PRODUCTS, INC. |
45 HARTWELL AVE. |
LEXINGTON,
MA
02173
|
|
Applicant Contact |
STEVEN ARMSTRONG |
Correspondent |
PALOMAR MEDICAL PRODUCTS, INC. |
45 HARTWELL AVE. |
LEXINGTON,
MA
02173
|
|
Correspondent Contact |
STEVEN ARMSTRONG |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/03/1998 |
Decision Date | 05/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|